510(k) · Cleared
ClearedRadio Frequency Ablation System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. · GEI Electrosurgical, Cutting & Coagulation & Accessories
Cleared on Jun 25, 2019 as substantially equivalent to K052796 (Valleylab, 2006) after a 165-day review. Its family tree reaches back 6 generations to 1987. 2 later devices descend from it.
- Decided
- Jun 25, 2019
- Review
- 165 days
- Class
- Class II
- Product code
- GEI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K870028 (1987). 17 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK870028 SMK Sluyter-Mehta Cannulae, RF Pole, Pole,FlexibleRadionics, Inc. · 1987
- 5 generations backK963577 Radionics Sluijter-Mehta CannulaRadionics, Inc. · 1996
- 4 generations backK980430 Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS)Radionics, Inc. · 1998
- 3 generations backK021329 Rita SystemRita Medical Systems · 2002
- 2 generations backK042216 Cool-Tip RF Ablation SystemValleylab · 2004
- 1 generation backK052796 Cool-Tip RF Generator, Cool-Tip RF System AccessoriesValleylab · 2006
- This deviceK190052 Radio Frequency Ablation SystemSurgnova Healthcare Technologies (Zhejiang) Co., Ltd. · 2019
- Descendant · cites it directly · 1 of its ownK233705 CellFX Percutaneous Electrode System (SYS3000)Pulse Biosciences, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK240782 CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous…Pulse Biosciences, Inc. · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K870028 | SMK Sluyter-Mehta Cannulae, RF Pole, Pole,Flexible | Radionics, Inc. | 1987 | — |
| −5 | K963577 | Radionics Sluijter-Mehta Cannula | Radionics, Inc. | 1996 | — |
| −4 | K980430 | Radionics Disposable RF Cannulae (SC-C, RFK-DB, RFK-DS) | Radionics, Inc. | 1998 | — |
| −3 | K021329 | Rita System | Rita Medical Systems | 2002 | — |
| −2 | K042216 | Cool-Tip RF Ablation System | Valleylab | 2004 | — |
| −1 | K052796 | Cool-Tip RF Generator, Cool-Tip RF System Accessories | Valleylab | 2006 | — |
| 0 (this device) | K190052 | Radio Frequency Ablation System | Surgnova Healthcare Technologies (Zhejiang) Co., Ltd. | 2019 | — |
| +1 | K233705 | CellFX Percutaneous Electrode System (SYS3000) | Pulse Biosciences, Inc. | 2024 | — |
| +2 | K240782 | CellFX Percutaneous Electrode System (SYS3000); CellFX Percutaneous Electrode… | Pulse Biosciences, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEI? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEI device
- #1 K231790 The InMode System with the Morpheus8 Applicatorsscore 32.7 · 21 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K052796 | Cool-Tip RF Generator, Cool-Tip RF System AccessoriesSummary page 4…ting and coagulation device and accessories Regulation Number: 878.4400 Product Code: GEI Class: II Panel: General & Plastic Surgery 3.3 Predicate Device 510(k) Number: K052796 Device Trade/Proprietary Name: Cool-tipTM RF Ablation System Common/Classification Name: Electrosurgical cutting and coagulation… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K233705 | CellFX Percutaneous Electrode System (SYS3000) | 2024 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 4 companies; a new generation was cleared every 4.6 years on median.
- 4 of the 17 ancestors have a recall of any class.
- Of its descendants, K233705 (Pulse Biosciences, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K052796.
How does its category compare?
All GEI devicesGEI Electrosurgical, Cutting & Coagulation & Accessories: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, this device’s year, is highlighted.
FDA decisions per year · GEI
52in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEI
113in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEI
4in 2025
Class I (14 since 2007) Class II/III not classified
Adverse event reports per year · GEI
7,592in 2025
MAUDE reports naming product code GEI, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 50 | 51 | 21 | 2,795 |
| 2008 | 61 | 71 | 19 | 2,556 |
| 2009 | 42 | 130 | 27 | 3,591 |
| 2010 | 46 | 109 | 51 | 3,377 |
| 2011 | 35 | 135 | 32 | 4,463 |
| 2012 | 39 | 133 | 30 | 5,216 |
| 2013 | 48 | 136 | 13 | 4,897 |
| 2014 | 49 | 103 | 3 | 4,908 |
| 2015 | 47 | 123 | 4 | 4,936 |
| 2016 | 64 | 108 | 3 | 5,616 |
| 2017 | 52 | 72 | 2 | 6,073 |
| 2018 | 47 | 93 | 6 | 6,545 |
| 2019 | 48 | 93 | 5 | 7,067 |
| 2020 | 59 | 105 | 1 | 6,490 |
| 2021 | 46 | 146 | 6 | 6,354 |
| 2022 | 55 | 150 | 49 | 6,103 |
| 2023 | 65 | 104 | 27 (4) | 7,176 |
| 2024 | 59 | 125 | 22 (10) | 7,897 |
| 2025 | 52 | 113 | 4 | 7,592 |
| 2026 | 43 | 183 | 8 | — |
What is it indicated for?
The Radio Frequency Ablation System is intended for coagulation and ablation of soft tissue. It is not intended for use in cardiac procedures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190052 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190052: Radio Frequency Ablation System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190052
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026